A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer

NCT07505771 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IM-3050-101
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief Summary

IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.

Conditions

Solid Malignancies

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)

  Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 6.0, including adverse events (SAEs), AEs leading to discontinuation, and deaths

  From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious; up to approximately 5 years

• Determine the recommended dose of 177Lu-IM-3050 for further development

  Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE criteria version 6.0, including SAEs, AEs leading to discontinuation, and deaths

  From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment; up to approximately 5 years

Secondary Outcomes (10)

• Time course of blood radioactivity of 177Lu-IM-3050

  Through 42-49 days following last dose of 177Lu-IM-3050

• Time course of blood radioactivity of 177Lu-IM-3050

  Through 42-49 days following last dose of 177Lu-IM-3050

• Time course of plasma IM-3050

  Through 42-49 days following last dose of 177Lu-IM-3050

• Time course of plasma IM-3050

  Through 42-49 days following last dose of 177Lu-IM-3050

• Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors

  Week 6 until disease progression or participant discontinuation from study

Study Arms (2)

Dose Escalation: 177Lu-IM-3050

EXPERIMENTAL

177Lu-IM-3050 administered intravenously on a 6-week cycle

Drug: 177Lu-IM-3050

Dose Expansion: 177Lu-IM-3050

EXPERIMENTAL

177Lu-IM-3050 administered intravenously on a 6-week cycle

Drug: 177Lu-IM-3050

Interventions

177Lu-IM-3050 DRUG

177Lu-IM-3050 is a FAP-directed radiopharmaceutical

Dose Escalation: 177Lu-IM-3050; Dose Expansion: 177Lu-IM-3050

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2
• Histological or cytological diagnosis of a solid tumor
• Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit.
• Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening.
• During Part A only, participants without measurable disease per RECIST v1.1 are eligible if approved by Medical Monitor.
• During screening, participants must have positive FAP PET/CT uptake as described in criteria for continuation of IM-3050 treatment.
• Participants must have adequate organ function.

You may not qualify if:

• Participant has received certain prior radiation therapy as detailed in the protocol
• Participant has undergone major surgery within 4 weeks or minor surgery within 2 weeks of starting 177Lu-IM-3050 or has known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis.
• Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years and approved by the Medical Monitor.
• Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.
• Recent or ongoing serious infection or other significant medical condition as detailed in the protocol.
• Participant has received an investigational product or been treated with an investigational device within 30 days, or 5 half-lives prior to receiving the FAP PET/CT imaging tracer or 177Lu-IM-3050.

Sponsors & Collaborators

• Immunome, Inc.: lead

Study Sites (3)

Stanford University School of Medicine

Palo Alto, California, 94305, United States

RECRUITING

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, 77042, United States

RECRUITING

Central Study Contacts

Immunome Medical Monitor

CONTACT

425.939.7410; info@immunome.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 1, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2034
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (3)